Clonidine Hydrochloride

Product NDC
0228-2129
11-digit product format
002282129
Labeler code
0228
Product ID
0228-2129_860129c9-0bba-471e-a90c-b6bede1833b8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clonidine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Actavis Pharma, Inc.
Application
ANDA070976
Marketing category
ANDA
Marketing start
1995-01-03
Substance
CLONIDINE HYDROCHLORIDE
Active strength
.3 mg/1
Pharmacologic classes
Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A070976-001CLONIDINE HYDROCHLORIDECLONIDINE HYDROCHLORIDE0.3MGTABLET / ORALAB1986-12-16

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A070976-001AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A070976-001CLONIDINE HYDROCHLORIDE0.3MGTABLET / ORALAB1986-12-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070976-001CLONIDINE HYDROCHLORIDE0.3MGTABLET / ORALAB1986-12-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08A070976-001CLONIDINE HYDROCHLORIDE0.3MGTABLET / ORALAB1986-12-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070976-001CLONIDINE HYDROCHLORIDE0.3MGTABLET / ORALAB1986-12-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070976-001CLONIDINE HYDROCHLORIDE0.3MGTABLET / ORALAB1986-12-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070976-001CLONIDINE HYDROCHLORIDE0.3MGTABLET / ORALAB1986-12-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A070976-001CLONIDINE HYDROCHLORIDE0.3MGTABLET / ORALAB1986-12-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A070976-001CLONIDINE HYDROCHLORIDE0.3MGTABLET / ORALAB1986-12-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A070976-001CLONIDINE HYDROCHLORIDE0.3MGTABLET / ORALAB1986-12-16d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A070976-001CLONIDINE HYDROCHLORIDE0.3MGTABLET / ORALAB1986-12-16d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A070976-001CLONIDINE HYDROCHLORIDE0.3MGTABLET / ORALAB1986-12-1679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A070976-001CLONIDINE HYDROCHLORIDE0.3MGTABLET / ORALAB1986-12-16301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A070976-001CLONIDINE HYDROCHLORIDE0.3MGTABLET / ORALAB1986-12-161e350fbaab3a…
2024-05-31 18:47 UTC2024-05A070976-001CLONIDINE HYDROCHLORIDE0.3MGTABLET / ORALAB1986-12-168072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A070976-001CLONIDINE HYDROCHLORIDE0.3MGTABLET / ORALAB1986-12-165c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A070976-001CLONIDINE HYDROCHLORIDE0.3MGTABLET / ORALAB1986-12-165d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A070976-001CLONIDINE HYDROCHLORIDE0.3MGTABLET / ORALAB1986-12-164b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A070976-001CLONIDINE HYDROCHLORIDE0.3MGTABLET / ORALAB1986-12-1674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A070976-001CLONIDINE HYDROCHLORIDE0.3MGTABLET / ORALAB1986-12-16bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A070976-001CLONIDINE HYDROCHLORIDE0.3MGTABLET / ORALAB1986-12-16782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A070976-001CLONIDINE HYDROCHLORIDE0.3MGTABLET / ORALAB1986-12-1687673890dc5c…
2021-03-12 10:30 UTC2021-03A070976-001CLONIDINE HYDROCHLORIDE0.3MGTABLET / ORALAB1986-12-165aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A070976-001CLONIDINE HYDROCHLORIDE0.3MGTABLET / ORALAB1986-12-168869cabd3fbd…
2020-11-12 02:37 UTC2020-11A070976-001CLONIDINE HYDROCHLORIDE0.3MGTABLET / ORALAB1986-12-16c0c555d07b60…
2019-12-14 00:12 UTC2019-12A070976-001CLONIDINE HYDROCHLORIDE0.3MGTABLET / ORALAB1986-12-163f01610625f2…
2019-09-15 20:21 UTC2019-09A070976-001CLONIDINE HYDROCHLORIDE0.3MGTABLET / ORALAB1986-12-16b00525d2431f…
2019-07-19 19:46 UTC2019-07A070976-001CLONIDINE HYDROCHLORIDE0.3MGTABLET / ORALAB1986-12-16ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A070976-001CLONIDINE HYDROCHLORIDE0.3MGTABLET / ORALAB1986-12-166a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A070976-001CLONIDINE HYDROCHLORIDE0.3MGTABLET / ORALAB1986-12-161c564ffb4f44…
2023-12-20 04:57 UTC2023-12A070976-001CLONIDINE HYDROCHLORIDE0.3MGTABLET / ORALAB1986-12-16ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A070976-001CLONIDINE HYDROCHLORIDE0.3MGTABLET / ORALAB1986-12-16a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A070976-001CLONIDINE HYDROCHLORIDE0.3MGTABLET / ORALAB1986-12-169b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A070976-001CLONIDINE HYDROCHLORIDE0.3MGTABLET / ORALAB1986-12-16a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A070976-001CLONIDINE HYDROCHLORIDE0.3MGTABLET / ORALAB1986-12-163f0d92c62455…
2023-05-13 08:27 UTC2023-05A070976-001CLONIDINE HYDROCHLORIDE0.3MGTABLET / ORALAB1986-12-16053a50430f4f…
2023-01-26 05:58 UTC2023-01A070976-001CLONIDINE HYDROCHLORIDE0.3MGTABLET / ORALAB1986-12-163bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A070976-001CLONIDINE HYDROCHLORIDE0.3MGTABLET / ORALAB1986-12-163a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A070976-001CLONIDINE HYDROCHLORIDE0.3MGTABLET / ORALAB1986-12-16f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A070976-001CLONIDINE HYDROCHLORIDE0.3MGTABLET / ORALAB1986-12-16e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A070976-001CLONIDINE HYDROCHLORIDE0.3MGTABLET / ORALAB1986-12-16cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A070976-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070976-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A070976-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070976-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070976-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070976-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A070976-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A070976-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A070976-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A070976-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A070976-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A070976-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A070976-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A070976-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A070976-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A070976-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A070976-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A070976-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A070976-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A070976-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A070976-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A070976-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A070976-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A070976-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A070976-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A070976-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A070976-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A070976-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A070976-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A070976-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A070976-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A070976-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A070976-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A070976-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A070976-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A070976-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A070976-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A070976-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A070976-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A070976-001AB1cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
Clonidine Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLONIDINE HYDROCHLORIDE.3 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
W76I6XXF06Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
884173Internal RxNorm lookup
884185Internal RxNorm lookup
884189Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
a842ab83-3531-44dd-a8a8-64dd89e87026Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
45c8ba14-e378-46f0-b21f-1aad8e08c613Product name120250221
6920b0ed-30bc-b127-73e1-0713049bd41eProduct name920190618
6920b0ed-30bc-b127-73e1-0713049bd41eProduct name520171212
48f5a4fd-7cdc-dc04-771d-ce7a47326789Product name220150123
624cf764-e200-44b5-83c2-84526255adb5Product name120150107
47972e1b-c905-eeee-5e77-eb4538ad833cProduct name120140508
7667d8e2-e5be-36e1-4de7-231aa7fdaf5cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0228-2129-10Clonidine Hydrochloride100 in 1 BOTTLETABLET10018

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0228-2129-10EA - Each0228-21290bc78a62-4ff9-4873-ad4f-15b91476c88112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CLONIDINE HYDROCHLORIDEACTIVE INGREDIENTW76I6XXF06CLONIDINE HYDROCHLORIDE TABLET [MAJOR PHARMACEUTICALS]9
CLONIDINEACTIVE MOIETYMN3L5RMN02CLONIDINE HYDROCHLORIDE TABLET [MAJOR PHARMACEUTICALS]9
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GCLONIDINE HYDROCHLORIDE TABLET [MAJOR PHARMACEUTICALS]9
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8CLONIDINE HYDROCHLORIDE TABLET [MAJOR PHARMACEUTICALS]9
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCLONIDINE HYDROCHLORIDE TABLET [MAJOR PHARMACEUTICALS]9
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CLONIDINE HYDROCHLORIDE TABLET [MAJOR PHARMACEUTICALS]9
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2CLONIDINE HYDROCHLORIDE TABLET [MAJOR PHARMACEUTICALS]9
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCLONIDINE HYDROCHLORIDE TABLET [MAJOR PHARMACEUTICALS]9
CLONIDINE HYDROCHLORIDEACTIVE INGREDIENTW76I6XXF06CLONIDINE HYDROCHLORIDE TABLET [ACTAVIS ELIZABETH LLC]7
CLONIDINEACTIVE MOIETYMN3L5RMN02CLONIDINE HYDROCHLORIDE TABLET [ACTAVIS ELIZABETH LLC]7
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GCLONIDINE HYDROCHLORIDE TABLET [ACTAVIS ELIZABETH LLC]7
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8CLONIDINE HYDROCHLORIDE TABLET [ACTAVIS ELIZABETH LLC]7
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCLONIDINE HYDROCHLORIDE TABLET [ACTAVIS ELIZABETH LLC]7
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CLONIDINE HYDROCHLORIDE TABLET [ACTAVIS ELIZABETH LLC]7
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2CLONIDINE HYDROCHLORIDE TABLET [ACTAVIS ELIZABETH LLC]7
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCLONIDINE HYDROCHLORIDE TABLET [ACTAVIS ELIZABETH LLC]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0228-2129CLONIDINE HYDROCHLORIDE TABLET [ACTAVIS PHARMA, INC.]17Current NDC, Legacy NDC, 1 package rows20231216_a842ab83-3531-44dd-a8a8-64dd89e87026.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Clonidine HydrochlorideCLONIDINE HYDROCHLORIDEBluePoint Laboratories1ea412db-d847-4094-be83-e3bd7328537a2025-11-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070976
application number: ANDA070976
Clonidine HydrochlorideCLONIDINE HYDROCHLORIDENCS HealthCare of KY, LLC dba Vangard Labsacdddd91-ffe3-4b9b-9c59-0328e018b6622024-08-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070976
application number: ANDA070976
Clonidine HydrochlorideCLONIDINE HYDROCHLORIDEActavis Pharma, Inc.a842ab83-3531-44dd-a8a8-64dd89e870262022-09-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070976
application number: ANDA070976
ndc (product): 0228-2129
Clonidine HydrochlorideCLONIDINE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLCe9b22c56-a3fc-46df-b745-11c4ac309a912017-05-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070976
application number: ANDA070976

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
884173cloNIDine HCl 0.1 MG Oral TabletPSNa842ab83-3531-44dd-a8a8-64dd89e8702618
884185cloNIDine HCl 0.2 MG Oral TabletPSNa842ab83-3531-44dd-a8a8-64dd89e8702618
884189cloNIDine HCl 0.3 MG Oral TabletPSNa842ab83-3531-44dd-a8a8-64dd89e8702618
884173clonidine hydrochloride 0.1 MG Oral TabletSCDa842ab83-3531-44dd-a8a8-64dd89e8702618
884185clonidine hydrochloride 0.2 MG Oral TabletSCDa842ab83-3531-44dd-a8a8-64dd89e8702618
884189clonidine hydrochloride 0.3 MG Oral TabletSCDa842ab83-3531-44dd-a8a8-64dd89e8702618
884173clonidine HCl 100 MCG Oral TabletSYa842ab83-3531-44dd-a8a8-64dd89e8702618
884185clonidine HCl 200 MCG Oral TabletSYa842ab83-3531-44dd-a8a8-64dd89e8702618
884189clonidine HCl 300 MCG Oral TabletSYa842ab83-3531-44dd-a8a8-64dd89e8702618
884189cloNIDine HCl 0.3 MG Oral TabletPSNacdddd91-ffe3-4b9b-9c59-0328e018b6627
884189clonidine hydrochloride 0.3 MG Oral TabletSCDacdddd91-ffe3-4b9b-9c59-0328e018b6627
884189clonidine HCl 300 MCG Oral TabletSYacdddd91-ffe3-4b9b-9c59-0328e018b6627
884189cloNIDine HCl 0.3 MG Oral TabletPSNe9b22c56-a3fc-46df-b745-11c4ac309a911
884189clonidine hydrochloride 0.3 MG Oral TabletSCDe9b22c56-a3fc-46df-b745-11c4ac309a911
884189clonidine HCl 300 MCG Oral TabletSYe9b22c56-a3fc-46df-b745-11c4ac309a911

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0228-2129-1000228212910100 TABLET in 1 BOTTLE (0228-2129-10) 100 tablet1995-01-030000-00-00NoNoCurrent